An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis
A PHASE 2, 16 WEEK, MULTICENTER, RANDOMIZED, DOUBLE BLIND PLACEBO CONTROLLED, PARALLEL GROUP PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PF-04383119 FOR THE TREATMENT OF PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS
2 other identifiers
interventional
65
1 country
34
Brief Summary
The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2008
Shorter than P25 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2008
CompletedFirst Posted
Study publicly available on registry
January 28, 2008
CompletedStudy Start
First participant enrolled
March 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2009
CompletedResults Posted
Study results publicly available
May 13, 2021
CompletedMay 13, 2021
April 1, 2021
1.1 years
January 15, 2008
April 20, 2021
April 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Average Daily Pain Score at Week 6
Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Here, 'Number analyzed' = participants with available data for each specified category.
Baseline, Week 6
Secondary Outcomes (45)
Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16
Baseline, Week 2, 4, 10, 16
Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16
Baseline, Week 2, 4, 6, 10, 16
Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16
Baseline, Week 2, 4, 6, 10, 16
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16
Baseline, Week 2, 4, 6, 10, 16
Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16
Baseline, Week 2, 4, 6, 10, 16
- +40 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male and female adults at least 18 years of age;
- Moderate to severe interstitial cystitis, with a mean pain intensity score above a pre-defined level.
You may not qualify if:
- Less than 6 months since onset of interstitial cystitis symptoms;
- History of recurrent urinary tract infections, or genitourinary cancer;
- History of hepatitis B, C or human immunodeficiency virus (HIV);
- Use of certain drugs given into the bladder up to 1 month prior to study entry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (34)
Pivotal Research Center
Peoria, Arizona, 85381, United States
Urology Associates of Central California
Fresno, California, 93710, United States
Citrus Valley Medical Research Inc.
Glendora, California, 91741, United States
SD Uro-Research
San Diego, California, 92103, United States
Boulder Medical Center
Boulder, Colorado, 80304, United States
Hartford Hospital, Urogynecology Division
Hartford, Connecticut, 06106, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
The Connecticut Clinical Research Center, Urology Specialists PC
Middlebury, Connecticut, 06762, United States
Waterbury Neurology
Middlebury, Connecticut, 06762, United States
Connecticut Urological Research at Grove Hill
New Britain, Connecticut, 06052, United States
Coastal Connecticut Research, LLC
New London, Connecticut, 06320, United States
Timothy M. Barczak, MD, LLC
New London, Connecticut, 06320, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Metropolitan Urology
Jeffersonville, Indiana, 47130, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
Chesapeake Urology Research Associates
Owings Mills, Maryland, 21117, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Michigan Institute of Urology
Troy, Michigan, 48084, United States
Michigan Institute of Urology
Utica, Michigan, 48313, United States
Barnes Jewish West County Hospital
St Louis, Missouri, 63141, United States
Washington University, Division of Urologic Surgery
St Louis, Missouri, 63141, United States
Washington University
St Louis, Missouri, 63141, United States
Quality Clinical Research Inc
Omaha, Nebraska, 68114, United States
The Arthur Smith Institute for Urology
New Hyde Park, New York, 11040, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Alliance Urology Specialists, PA
Greensboro, North Carolina, 27403, United States
Tri-State Urologic Services PSC, Inc. dba The Urology Group
Cincinnati, Ohio, 45212, United States
Parkhurst Research Organization, LLC
Bethany, Oklahoma, 73008, United States
Triangle Urological Associates
Pittsburgh, Pennsylvania, 15212, United States
Matrix Research, LLC (Administrative Only)
Greer, South Carolina, 29650, United States
The Urology Group
Greer, South Carolina, 29650, United States
Mobley Research Center
Houston, Texas, 77024, United States
Integrity Medical Research, LLC
Mountlake Terrace, Washington, 98043, United States
Northside Internal Medicine
Spokane, Washington, 99208, United States
Related Publications (1)
Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
PMID: 32734597DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2008
First Posted
January 28, 2008
Study Start
March 17, 2008
Primary Completion
April 15, 2009
Study Completion
April 15, 2009
Last Updated
May 13, 2021
Results First Posted
May 13, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.